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TranscriptFY2025 Q42026-03-30FY2025 Q4 earnings call transcript
Earnings source - 36 paragraphs
FY2025 Q4 earnings call transcript
Type your question in. With us today are Enlivex's Executive Chairman, Shai Novik, and Chief Executive Officer, Oren Hershkovitz. I'd like to start by reminding you that certain comments on this call are forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Please review the forward-looking and cautionary statements section at the end of the company's Q4 and full year 2025 earnings press release for various factors that could cause actual results to differ materially from forward-looking statements made during the call today. Any forward-looking statements made during this call speak only as of today's date and reflect the company's current views with respect to future events, and Enlivex is under no obligation to update or revise forward-looking statements made on this call, whether as a result of new information, future events, or otherwise, except as required by law.
I'd also like to remind everyone that today's call is being recorded and an archived version of the call will be available on the company's website as promptly as possible after the call. With that, I'd like to turn the call over to Enlivex's Chairman, Shai Novik. Shai?
Thank you, Craig Brelsford, and welcome everyone. I appreciate you joining us today. 2025 was a defining and transformational year for Enlivex. This was the year in which we made several bold moves and firmly established Enlivex in what we believe is a new category in the public markets, a quality longevity company powered by a prediction markets treasury. Or more simply put, a company operating at the intersection of health span and what we call wealth span. We'll get to it a little later. Our strategy is built on a clear and differentiated foundation. At its core, we believe that Enlivex brings together two powerful capabilities. On the one hand, we are advancing a clinical stage platform focused on common, underserved, longevity-related assets, where we believe we can deliver meaningful therapeutic impact on the quality of extended longevity.
At the same time, we have built a treasury architecture designed to capture value from the emerging prediction markets economy. What is important is not just the presence of these two capabilities, but how they work together. This combination allows us to operate our clinical development through a capital strategy aligned with one of the fastest-growing areas of financial infrastructure. This is what we refer to as our dual-engine model, or more broadly, the convergence of biology and financial infrastructure into a single institutional framework. This strategy transformation is directly reflected in our 2025 financial results. For the full year, we generated $1.23 billion in net income and $25.48 in earnings per share.
These results were driven by the appreciation of our treasury and treasury-related assets, and more importantly, we believe they represent the early validation of our treasury strategy in a rapidly institutionalizing market. We do not view this as a one-time event. We believe this is the initial expression of a repeatable and scalable capital strategy aligned with the growth of prediction markets as a new financial category. Stepping back, what is important here is not just the performance in a single year. It is the structural opportunity we are positioning the company around. Prediction markets are evolving from an experimental concept into what we believe will become the core layer of global financial infrastructure. We have been seeing this reflected in growing trading volumes and expanding real-world utility in forecasting and risk pricing. Importantly, this shift is now being validated by meaningful institutional capital entering the space.
Enlivex today provides one of the only institutional-grade GAAP-compliant vehicles in equity markets through which investors can access the prediction markets opportunity within the traditional public equity framework. Let me now turn to what we believe is one of the most compelling aspects of our model. As part of our strategic partnership with the Rain Foundation, which independently oversees the decentralized prediction markets Rain Protocol, we secured an exclusive one-year option to acquire up to 275 billion Rain tokens at a fixed price of $0.0033 per token, which is substantially below current price of the token today. This is not simply an acquisition mechanism. This is best understood as an embedded high convexity growth engine within our capital structure. In more familiar terms, it functions as a warrant-like component embedded in our equity, providing potentially meaningful upside participation without immediate dilution.
Yesterday, we announced a series of updates which are tied to this option and other value creation efforts. We entered into a $21 million debt financing agreement with a New York-based institutional fund manager, and we plan to use the net proceeds from this financing to fund both our clinical development efforts as well as to acquire additional 3 billion RAIN tokens at a substantial discount to its closing price, two days ago for a total aggregated purchase price of $10 million. In addition, we announced that together with the Rain Foundation, we extended our RAIN token purchase option, which was originally scheduled to expire November 30th, 2026. It's now December 31st, 2027.
Keeping the same exercise price, strategically, this gives us the ability to potentially raise capital opportunistically and deploy that capital at structurally advantaged pricing, allowing us to expand our treasury in a way intended to enhance long-term shareholder value. At the same time, hopefully the RAIN centralized prediction markets protocol continue to build itself into a leading player. Lastly, we announced that our board of directors approved the adoption of a share repurchase program to acquire up to $20 million of our outstanding ordinary shares, subject to satisfaction of meeting applicable regulatory requirements.
The note we issued is a convertible, and it's convertible after a 90-day holding period, which means that they cannot convert it in the first 90 days, and it's converted into our ordinary shares at a fixed conversion price of approximately $2.69, which represents a 264% premium to the Nasdaq closing price of our stock on Friday. We believe that this unusually high conversion premium and the associated limitations on any conversion in the next three months represent the conviction of the institutional investor of the attractiveness of our strategy. At the same time, our clinical engine remains central to our identity and long-term value. Allocetra has continued to demonstrate clinically meaningful and statistically significant results alongside a favorable safety profile, and we see a clear pathway toward late-stage development in osteoarthritis and other inflammatory indications.
The clinical platform is not separate from our treasury strategy, it is complementary. It provides what we describe as a biological floor to our overall value proposition, helping balance volatility while advancing meaningful therapeutic innovation. We reported two days ago that the FDA has cleared our investigational drug application for a late-stage Phase IIb clinical trial in knee osteoarthritis, a debilitating disease that negatively affects the quality of life of tens of millions in the United States. This is big news for us, and we are moving forward strongly. Ultimately, we believe Enlivex is not easily categorized within traditional sectors. We're not simply a quality longevity company. We're not simply a digital asset treasury company. We are building what we believe is a new institutional archetype, a company designed to capture value across both scientific innovation and emerging financial infrastructure.
as we describe it internally, we are the architects of the future, building the foundation for a new class of public companies. With that, I will turn the call over to Oren, who will talk through our 2025 financial results in more detail and provide deeper insight into the execution of our treasury strategy and clinical progress. Oren?
Thank you, Shai. Let me start with the headline numbers. For the full year 2025, we reported net income of $1.23 billion and diluted earnings per share of $25.48, which, in accordance with GAAP, is calculated based on the weighted average shares outstanding for the year. We ended the year with $2.31 billion in total treasury and treasury-related assets and $1.93 billion in shareholders' equity. As Shai mentioned, these results were driven by the appreciation in the valuation of our treasury and treasury-related assets. More specifically, these results reflect market-based revaluation of our strategic holdings aligned with the growth and increasing adoption of prediction markets as an emerging asset class. Importantly, what we are seeing is not isolated to Enlivex.
We believe it is a function of a broader structural momentum in the prediction markets ecosystem, which we have positioned ourselves to capture early. Let me take you a step back and explain how this works, 'cause ultimately the key question is not what happened in 2025, it is why we believe this model can continue to generate value over time. When we evaluated our treasury strategy, we were not looking for a digital asset portfolio that had already been used and copied by others. We were looking for a category with real utility, real adoption, and long-term structural growth. We believe that prediction markets meets all three criteria. At their core, prediction markets function as a mechanism for aggregating collective intelligence while also serving as a real-time system for pricing probability and future outcomes. Increasingly, they are evolving into a fundamental financial primitive for decision-making across markets.
We are already seeing this reflected in strong trading volumes, rapid user growth, and increasing institutional engagement, and we believe the category is still in the early stages. Within this category, we selected RAIN as our primary digital treasury reserve asset. The simplest way to think about RAIN is that it is like a TikTok of prediction markets. It is fully decentralized, permissionless, global, and designed to scale. Unlike centralized platforms where market creation and liquidity are inherently constrained, RAIN allows any user anywhere in any language to create and trade markets. That fundamentally changes the structure of the system. It enables a long tail supply of markets, support continuous liquidity through AMM-based mechanism, and drives a network effect that we believe is critical for long-term adoption and scale. What makes this even more powerful is the token model.
The protocol applies a 5% fee on total trading volume, with half of that used to buy back tokens from the open market and permanently burn them. As a result, there is direct linkage between protocol usage and long-term token supply dynamics. As activity increases, supply contracts, potentially concentrating value for long-term shareholders such as Enlivex. We refer to this as usage-driven value creation, and as a planned long-term holder and active participant, we believe Enlivex is positioned to benefit directly from that dynamic. From a balance sheet perspective, we believe we are well positioned with $1.93 billion in equity, a rapidly scaling treasury base, and significant capital flexibility. Our focus remains on disciplined deployment, ensuring that capital allocation continues to support both treasury expansion and the advancement of our clinical programs.
Let me now briefly touch on our clinical engine, which remains a critical component of our overall value proposition. Allocetra has demonstrated clinically meaningful and statistically significant results, a favorable safety profile, and durable improvements in pain and function in osteoarthritis patients. Looking ahead, we have a clear set of upcoming clinical milestones over the next 12-18 months. As Shai mentioned, we announced two days ago that the FDA has cleared our investigational drug application for a late-stage Phase IIb clinical trial in knee osteoarthritis. This is our first regulatory approval for a multicenter, multicountry, randomized, double-blind, placebo-controlled phase II-B trial in age-related moderate to severe knee osteoarthritis. From there, we expect to generate three and six-month top-line data in 2027, setting the stage for a pivotal phase III trial.
Enlivex's dedicated and experienced team is eager to push this clinical program forward as fast as possible and with the highest quality. It is important to emphasize that osteoarthritis is one of the most prevalent and disabling diseases worldwide, affecting more than 32 million Americans today and projected to impact 78 million Americans by 2040. Just in the U.S., by age 60, knee osteoarthritis affects roughly 30% of the population, and about half of knee osteoarthritis patients are 60 years and older. This demographic is expanding with global aging trends, underscoring the need for new durable therapies. Consequently, the $7 billion estimated market is expected to continue globally to expand substantially. Importantly, we believe our treasury strategy will enable us to advance these programs without relying solely on traditional capital markets financing. This is a key element of the hybrid model.
Let me close with a few broader thoughts. First, we believe we are still early in both engines. Prediction markets are in the early stages of institutional adoption, and our clinical program is advancing towards a late stage value inflection point. Second, there are currently very few, if any, public markets vehicles that provides this type of exposure in a compliant GAAP-based structure. That creates a degree of scarcity and positioning Enlivex as a potential gateway asset for investors seeking participation in this convergence. Finally, our focus remains consistent. Continue scaling our treasury strategy, continue advancing our clinical programs, and continue expanding institutional engagement around this model. We believe this combination, the integration of financial infrastructure and biological innovation, represents not just a strategy, but a new category of company, and we are committed to leading that category.
I want to thank the team for their continued dedication and execution and for the focus and commitment they bring to building this company every day. I want to thank our shareholders and partners for their ongoing support and confidence as we continue to advance this dual engine model. Thank you.
With that, we'll now open the call for questions. To ask a question, please press the Q&A button at the bottom of your screen and type your question in. We've already had a few questions come in. Our first one, crypto in general was down hard in 2025, and most of the other digital treasury companies out there posted or will post substantial losses for 2025. How come Enlivex is posting such large profits for 2025?
Yes, an excellent question. Crypto has had a tough period recently. The exposure of Enlivex through treasury is to prediction markets, specifically a decentralized prediction market token, RAIN, as you know. I think that the market has been very bullish on prediction markets recently, and that translated into the RAIN token valuation to increase, creating that value for Enlivex and creating those very large profits in contrast to what's been happening in crypto.
Thank you, Shai. Our next question. Your market cap is at a discount to your treasury valuation, something that we have started seeing across many digital treasury companies. How do you explain that?
Definitely. Crypto, we think, has been out of favor. As a result, most digital treasury companies have been out of favor as well, leading to what we call net asset value discounts. We hope that the prediction market ecosystem will continue growing, RAIN with it, and we believe that that discount for the net asset value of Enlivex will be diminished, going forward.
Thank you. Our next question that's come in. Biotech companies are usually defined by dilution and long timelines. Does this change how a clinical-stage company can be financed going forward?
This is a very interesting question. I think that the funding possibilities for earlier stage biotech companies have been minimized once the COVID era was kinda done, while the later stage projects which are close to FDA approval still have funding available. Therefore, you know, for earlier stage biotechs, it definitely used to be the question of what would be the dilution as a result of additional financings. Yet in the last 24 months or so, it's changed to a question of whether there is funding available at all, regardless of potential dilution. The model we implemented in Enlivex has been designed to, first of all, avoid that problem that was just mentioned. No funding available because earlier stage biotech capital availability is scarce? No problem. We would self-fund from a small percent of the appreciation in the treasury assets.
Does it solve for the basic dilution problem? Hopefully. As now the investors in Enlivex are owners of a dual strategy and would potentially share the value that may come from either the clinical development side and/or the treasury side.
Thank you. Our next question. This is one of the first times prediction markets infrastructure is reflected in public company earnings. Do you see this as a one-off outcome or is it the beginning of a broader shift?
Well, definitely we see this as a beginning of a broader shift. I mean, while we are currently, to the best of our knowledge, right, the only public traded company that provides investor with the ability to invest through an equity in prediction markets, we assume that this is just a beginning, you know, and that we will see additional such opportunities in the next few years.
Thank you. Our next question, from a public markets perspective, how should investors think about Enlivex now after these results?
Oren, maybe you want to take this one.
Yeah, sure. Thanks, Shai. Well, I think investors were waiting, you know, on the sidelines to get some initial clarity on the potential value creation of Enlivex with its prediction market treasury strategy. Clearly, post this earnings report, I believe that many investors are looking at Enlivex differently now, right, paying more attention to both sides of the dual model strategy.
Thank you. We have looks like one more question here. Looking ahead, what are the key drivers that will determine whether this model continues to scale?
You know, we believe that this would be determined by the value drivers of the dual engine model. Our working assumption is that the prediction markets ecosystem would continue to thrive in the next decade, and that alongside the growth in centralized prediction markets, there is going to be a substantial growth in decentralized prediction markets as well. We believe that RAIN would become one of the leading decentralized prediction markets, and that the RAIN token would become highly valuable upon that occurs. On the other side, we believe that our quality longevity clinical program will provide value as well, and that it's potentially substantial. These two pillars would define the scalability of the model, and there are many milestones that both are executing and trying to reach, and planning to reach during the next two years or so.
Thank you. That concludes our Q&A session. Were there any final comments that you would like to leave the audience?
Yes. Thank you. We wanna say thanks to everybody that joined in. We appreciate the questions that were asked, and we hope we provided clarity today with respect to our strategy, our planning, the scalability of our model, and the magnitude of the profits and earnings per share for 2025. We look forward to getting together with everybody in the next quarterly call. Thank you so much.
Thank you. That concludes today's call.
Investor releaseQuarter not tagged2026-03-25Enlivex Therapeutics Q4 Earnings Call Highlights
MarketBeat
Enlivex Therapeutics Q4 Earnings Call Highlights
Enlivex reported $1.23 billion in net income and $25.48 diluted EPS for 2025, ending the year with $2.31 billion in treasury assets and $1.93 billion in shareholders’ equity, results management attributed mainly to market-driven revaluation of prediction-market-linked holdings. The company is building a digital-asset treasury around the RAIN token, holding an exclusive option to buy up to 275 billion RAIN at $0.0033 per token (option extended to Dec. 31, 2027), and announced a $21 million debt financing, a planned purchase of 3 billion RAIN for $10 million, and a board-approved $20 million share repurchase program. Enlivex reiterated its clinical focus as FDA cleared a randomized, double-blind Phase IIb trial of Allocetra in knee osteoarthritis, with expected three- and six-month topline data in 2027 after prior signals of meaningful pain and function improvements. Interested in Enlivex Therapeutics Ltd.? Here are five stocks we like better. Enlivex Therapeutics (NASDAQ:ENLV) executives used the company’s fourth-quarter and full-year 2025 earnings call to outline what they described as a “dual-engine” strategy that combines clinical-stage drug development with a digital-asset treasury focused on decentralized prediction markets. Executive Chairman Shai Novik and CEO Oren Hershkovitz said 2025 marked a “defining and transformational year,” highlighted by a sharp rise in reported profitability driven primarily by treasury asset appreciation. Novik and Hershkovitz reported that Enlivex generated $1.23 billion in net income for full-year 2025, with diluted earnings per share of $25.48. Hershkovitz said the EPS figure was calculated in accordance with GAAP using the weighted average shares outstanding for the year. → Macy’s Beats Expectations Again, But Guidance Spooks Investors On the balance sheet, management said the company ended 2025 with $2.31 billion in total treasury and treasury-related assets and $1.93 billion in shareholders’ equity. Both executives emphasized that the results were driven by “appreciation” and “market-based revaluation” of treasury and related holdings tied to the prediction markets ecosystem. During the Q&A portion of the call, Novik addressed a question about why Enlivex posted large profits while “crypto in general was down hard in 2025.” He said Enlivex’s exposure was specifically to prediction markets via the RAIN token, and that…Read full documentShow less
Enlivex reported $1.23 billion in net income and $25.48 diluted EPS for 2025, ending the year with $2.31 billion in treasury assets and $1.93 billion in shareholders’ equity, results management attributed mainly to market-driven revaluation of prediction-market-linked holdings. The company is building a digital-asset treasury around the RAIN token, holding an exclusive option to buy up to 275 billion RAIN at $0.0033 per token (option extended to Dec. 31, 2027), and announced a $21 million debt financing, a planned purchase of 3 billion RAIN for $10 million, and a board-approved $20 million share repurchase program. Enlivex reiterated its clinical focus as FDA cleared a randomized, double-blind Phase IIb trial of Allocetra in knee osteoarthritis, with expected three- and six-month topline data in 2027 after prior signals of meaningful pain and function improvements. Interested in Enlivex Therapeutics Ltd.? Here are five stocks we like better. Enlivex Therapeutics (NASDAQ:ENLV) executives used the company’s fourth-quarter and full-year 2025 earnings call to outline what they described as a “dual-engine” strategy that combines clinical-stage drug development with a digital-asset treasury focused on decentralized prediction markets. Executive Chairman Shai Novik and CEO Oren Hershkovitz said 2025 marked a “defining and transformational year,” highlighted by a sharp rise in reported profitability driven primarily by treasury asset appreciation. Novik and Hershkovitz reported that Enlivex generated $1.23 billion in net income for full-year 2025, with diluted earnings per share of $25.48. Hershkovitz said the EPS figure was calculated in accordance with GAAP using the weighted average shares outstanding for the year. → Macy’s Beats Expectations Again, But Guidance Spooks Investors On the balance sheet, management said the company ended 2025 with $2.31 billion in total treasury and treasury-related assets and $1.93 billion in shareholders’ equity. Both executives emphasized that the results were driven by “appreciation” and “market-based revaluation” of treasury and related holdings tied to the prediction markets ecosystem. During the Q&A portion of the call, Novik addressed a question about why Enlivex posted large profits while “crypto in general was down hard in 2025.” He said Enlivex’s exposure was specifically to prediction markets via the RAIN token, and that the market had been “very bullish on prediction markets recently,” which he said increased the token’s valuation and contributed to Enlivex’s profits. → Microsoft’s Next AI Leg: Can MSFT Still Outperform From Here? Management described prediction markets as moving from an “experimental concept” toward a new layer of financial infrastructure, citing what they characterized as increasing trading volumes, expanding utility, and growing institutional engagement. Hershkovitz said the company’s treasury strategy was built around finding a category with “real utility, real adoption, and long-term structural growth,” and that Enlivex selected RAIN as its primary digital treasury reserve asset. Hershkovitz characterized RAIN as a decentralized, permissionless protocol designed to scale globally and allow users to create and trade markets broadly. He also described a token model in which the protocol applies a 5% fee on total trading volume, with half of that fee used to buy back tokens and permanently burn them, which he said links protocol usage to token supply dynamics. → Super Micro's Plunge: An AI Deep Value Opportunity? Novik said the company believes it offers “one of the only institutional-grade GAAP-compliant vehicles in equity markets” through which investors can access prediction markets exposure within a traditional public equity framework. Novik said Enlivex has a strategic partnership with the Rain Foundation, which he described as independently overseeing the decentralized prediction markets Rain Protocol. Through that partnership, he said Enlivex secured an exclusive one-year option to acquire up to 275 billion Rain tokens at a fixed price of $0.0033 per token, which he said was “substantially below” the token’s price at the time of the call. He also outlined several updates the company announced “yesterday,” including: $21 million debt financing agreement with a New York-based institutional fund manager. Novik said net proceeds are planned to support clinical development and acquire additional RAIN tokens. A planned purchase of an additional 3 billion RAIN tokens for an aggregated purchase price of $10 million, which Novik said would be at a substantial discount to the token’s closing price two days earlier. An extension of the RAIN token purchase option’s expiration date from November 30, 2026 to December 31, 2027, with the same exercise price. Board approval of a share repurchase program of up to $20 million, subject to satisfying applicable regulatory requirements. Novik added that the issued note is convertible after a 90-day holding period and converts into ordinary shares at a fixed conversion price of approximately $2.69, which he said represented a 264% premium to the Nasdaq closing price of the stock on the prior Friday. He said the premium and conversion limitations reflected the institutional investor’s conviction in the strategy. While much of the call focused on the treasury strategy, management reiterated that Enlivex’s clinical platform remains central to its long-term value. Novik and Hershkovitz said the company’s lead program, Allocetra, has shown “clinically meaningful and statistically significant results” with a favorable safety profile, including durable improvements in pain and function in osteoarthritis patients. Management reported that the FDA cleared the company’s investigational drug application for a late-stage Phase IIb clinical trial in knee osteoarthritis. Hershkovitz described it as a multicenter, multicountry, randomized, double-blind, placebo-controlled Phase IIb trial in age-related moderate to severe knee osteoarthritis. Looking ahead, Hershkovitz said the company expects to generate three- and six-month top-line data in 2027, which he said would set the stage for a pivotal Phase III trial. Hershkovitz also highlighted the prevalence of osteoarthritis, stating it affects more than 32 million Americans today and is projected to impact 78 million Americans by 2040. He said the estimated market is about $7 billion and expected to expand globally. In response to a question about the company’s market capitalization trading at a discount to its treasury valuation, Novik said digital treasury companies have been “out of favor,” leading to net asset value discounts. He said the company hopes continued growth in the prediction market ecosystem and RAIN could help diminish that discount over time. Asked whether Enlivex’s model changes how a clinical-stage biotech can be financed, Novik said earlier-stage biotech funding availability has become scarce in the past two years. He said Enlivex designed its model to potentially self-fund using a small percentage of treasury asset appreciation, with investors participating in potential value from both the clinical and treasury sides. Management said the key drivers for scaling the model include continued growth of the prediction markets ecosystem—particularly decentralized prediction markets and RAIN’s potential position within them—alongside progress in Enlivex’s longevity-focused clinical programs. Enlivex Therapeutics is a clinical-stage biopharmaceutical company headquartered in Ness Ziona, Israel, that focuses on developing innovative immunotherapies for life-threatening inflammatory conditions. Founded in 2015, the company trades on the NASDAQ under the symbol ENLV and leverages a proprietary cell-based platform to restore immune balance in critical care settings. The company's lead product candidate, Allocetra, comprises reprogrammed apoptotic cell therapy designed to recalibrate the innate immune system. The article "Enlivex Therapeutics Q4 Earnings Call Highlights" was originally published by MarketBeat.
Investor releaseQuarter not tagged2025-09-11Enlivex CEO Issues Letter to Shareholders Outlining Strategic Roadmap Following Positive Phase IIa Allocetra™ Results
GlobeNewswire
Enlivex CEO Issues Letter to Shareholders Outlining Strategic Roadmap Following Positive Phase IIa Allocetra™ Results
Nes-Ziona, Israel, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, today issued the following update to shareholders from Chief Executive Officer, Oren Hershkovitz, highlighting the strength of its recently announced Phase IIa topline results for Allocetra™ in knee osteoarthritis (KOA) and detailing the next steps planned for its clinical development roadmap. Dear fellow shareholders, I would like to take this opportunity to provide you with our perspective on our recent Phase IIa (ENX-CL-05-001) 3-month topline data readout for Allocetra™ in patients with moderate-to-severe KOA. We believe that these three-month results represent a key positive milestone for Enlivex. After a careful analysis of the data and discussions with multiple physicians and experts who are among the world-leaders in the area of KOA, we believe that Allocetra™ has the potential to become a leading therapy of choice for the tens of millions of patients with primary (idiopathic, age-related) KOA, who currently have few and poor treatment options for this debilitating disease. Having received many calls from investors after announcing the positive 3-month data, we would like to reiterate that we believe that, notwithstanding recent stock price movements, the clinical data and expert validation are clear. We further believe Allocetra™ is well positioned to advance toward late-stage development and ultimately address a major unmet need in KOA. Positive Feedback from Analysts and Key Opinion Leaders Reinforce Confidence in Allocetra™ To underscore this, it is important to highlight the enthusiasm not only from our team but also from respected industry analysts and key opinion leaders. One of those analysts is Jason Kolbert, M.Sc., a long-time biotech analyst who covers Enlivex. He started his August 22, 2025, report by stating, “Enlivex reported what we, along with every expert we consulted, viewed not just as good but truly exceptional data in its knee osteoarthritis program”. He continues to provide insight into what has technically transpired, and I highly recommend that you obtain a full copy of his research report, as well as the recent H.C. Wainwright research report from Raghuram Selvaraju, Ph.D., a notable veteran life sciences analyst, dated September 2, 2025 discussing the…Read full documentShow less
Nes-Ziona, Israel, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, today issued the following update to shareholders from Chief Executive Officer, Oren Hershkovitz, highlighting the strength of its recently announced Phase IIa topline results for Allocetra™ in knee osteoarthritis (KOA) and detailing the next steps planned for its clinical development roadmap. Dear fellow shareholders, I would like to take this opportunity to provide you with our perspective on our recent Phase IIa (ENX-CL-05-001) 3-month topline data readout for Allocetra™ in patients with moderate-to-severe KOA. We believe that these three-month results represent a key positive milestone for Enlivex. After a careful analysis of the data and discussions with multiple physicians and experts who are among the world-leaders in the area of KOA, we believe that Allocetra™ has the potential to become a leading therapy of choice for the tens of millions of patients with primary (idiopathic, age-related) KOA, who currently have few and poor treatment options for this debilitating disease. Having received many calls from investors after announcing the positive 3-month data, we would like to reiterate that we believe that, notwithstanding recent stock price movements, the clinical data and expert validation are clear. We further believe Allocetra™ is well positioned to advance toward late-stage development and ultimately address a major unmet need in KOA. Positive Feedback from Analysts and Key Opinion Leaders Reinforce Confidence in Allocetra™ To underscore this, it is important to highlight the enthusiasm not only from our team but also from respected industry analysts and key opinion leaders. One of those analysts is Jason Kolbert, M.Sc., a long-time biotech analyst who covers Enlivex. He started his August 22, 2025, report by stating, “Enlivex reported what we, along with every expert we consulted, viewed not just as good but truly exceptional data in its knee osteoarthritis program”. He continues to provide insight into what has technically transpired, and I highly recommend that you obtain a full copy of his research report, as well as the recent H.C. Wainwright research report from Raghuram Selvaraju, Ph.D., a notable veteran life sciences analyst, dated September 2, 2025 discussing the positive results. Highly positive and encouraging feedback came up during our discussions of the 3-month results with key opinion leaders in KOA. Prof. Ali Mobasheri, a Professor of Musculoskeletal Biology in the Faculty of Medicine, University of Oulu, Finland, is one of world’s leading experts on osteoarthritis and has been serving as a clinical advisor to Enlivex for the last two years. He is the former President of the Osteoarthritis Research Society International (OARSI), the leading medical society for advancing the understanding, early detection, treatment and prevention of osteoarthritis. Prof. Mobasheri participated in, and consulted on, most clinical trials in osteoarthritis during the last 15 years. When we asked for Prof. Mobasheri’s insight on the trial’s 3-month data, he stated, “this positive effect that you have seen in the older patient population is quite intriguing, and it fits nicely with the distinct type of age-related osteoarthritis that is highly prevalent in that population. It is very impressive to obtain such statistical significance in a relatively small patient population, and I highly recommend that you move forward into the next Phase IIb. You may have something here that could change the life of OA idiopathic patients, and I urge you to continue to explore this.” Key Study Findings Highlight Allocetra™’s Potential in Patients with Age-Related Osteoarthritis I would like to reiterate some of the key 3-month findings of the study. In addition to assessing the overall safety and efficacy of Allocetra, the study included assessments aiming to find a high-responder patient population, because the term “osteoarthritis” represents a collection of clinical conditions rather than one molecular disease. This means there are multiple pathways for inflammation in osteoarthritis, and AllocetraTM may be suitable for specific pathways, taking into consideration its proposed mechanism of action. This objective was met, and in primary idiopathic age-related osteoarthritis patients (≥60 years), a population representing more than half of the total KOA market and 54% of the study population, Allocetra™ achieved substantial, clinically meaningful and highly statistically significant improvement compared to the control placebo group in pain and function. Efficacy was assessed by the FDA-accepted questionnaire assessing knee pain, function and stiffness (WOMAC -Western Ontario and McMaster Universities Arthritis Index, a validated patient reported questionnaire assessing pain, function and stiffness). The treatment effect as represented in the reduction of pain and improvement in function comprises potential Phase III primary endpoints are commonly accepted by the FDA. The following results were observed: 72% reduction in pain vs. placebo and absolute reduction of 49% from baseline in the AllocetraTM arm 109% improvement in function vs. placebo and absolute reduction of 50% from baseline in the AllocetraTM arm Efficacy exceeding FDA thresholds for Phase III trials These improvements demonstrated even greater effects and statistical significance with aging, as we further enrich the responder primary idiopathic age-related osteoarthritis patients. Allocetra™ was well tolerated, with no drug-related serious adverse events, and mostly mild-to-moderate, transient local reactions were observed. Significance for the Knee Osteoarthritis Market KOA is one of the most prevalent and disabling diseases globally, affecting more than 32 million Americans today and projected to impact 78 million by 2040. Despite this enormous burden, there are no approved disease-modifying treatments, with current options limited to pain relief, steroids, or surgery. The prevalence of KOA increases with age, as the progressive degeneration of the joint surface evolves. By the age of 60 years, the prevalence increases to 30% of the entire population, and 50% of patients with knee OA are aged 60 and above. The prevalence of KOA is expected to grow significantly due to the rising geriatric population worldwide and the associated increase in the prevalence of osteoarthritis. This strengthens the importance of the clinical effect observed by AllocetraTM in the age-related primary idiopathic aging population, as a promising therapy that may change the life of a substantial OA population, which is expected to increase over time. Next Steps and Key Milestones Building on these strong results, Enlivex is advancing Allocetra™ toward late-stage development with a planned roadmap of catalysts: November 2025: Six-month readout from the ongoing Phase IIa trial 2026 (Q1–Q2): Expected regulatory approval of Phase IIb protocol 2026 (Q2–Q3): Expected dosing of first patient in Phase IIb trial focused on primary KOA patients 2027 (Q2–Q3): Expected three- and six-month topline data from Phase IIb trial We believe that the positive 3-month topline data from the Phase IIa trial position Enlivex as a strong candidate for a potential partnership with a larger company that has an interest in osteoarthritis, as well as for securing other non-dilutive funding opportunities. We are currently pursuing both. We remain focused on rapidly executing our clinical roadmap and look forward to potentially unlocking the significant medical and market opportunity, while delivering enduring value for patients and shareholders. About ENX-CL-05-001 ENX-CL-05-001 is a multi-center Phase I/II clinical trial consisting of two stages. The first stage was a Phase I safety run-in, open-label dose escalation phase to characterize the safety and tolerability of Allocetra™ injections to the target knee, in order to identify the dose and injection regimen for the subsequent Phase IIa stage. The Phase IIa stage is a double-blind, randomized, placebo-controlled multi-centered trial. In addition to evaluating safety, the study protocol was designed to efficiently find a strong signal in a responder population to guide future development, and includes an interim statistical evaluation, conducted by an independent third party and blinded to Enlivex, to assess the potential value of enrollment of up to 50 patients in addition to the original randomized sample size of 130, and its marginal impact on the p-value of the statistical estimation of the total group and specifically to identify a potential responder sub-group. The trial’s key efficacy endpoints evaluate joint-pain and joint-function in comparison to placebo at three months, six months and 12 months post treatment. ABOUT KNEE OSTEOARTHRITIS Osteoarthritis is by far the most common form of arthritis, affecting more than 32.5 million Americans and more than 300 million individuals worldwide. About half of knees with ACL injuries develop osteoarthritis within 5 to 15 years. 78 million Americans are projected to have osteoarthritis by the year 2040. Symptomatic knee osteoarthritis is particularly prevalent and disabling, with 40% of men and 47% of women developing knee osteoarthritis in their lifetimes. Osteoarthritis accounts for over one million hospitalizations annually in the United States, primarily for total joint replacement. Osteoarthritis is an heterogenous complex condition and not a single molecular derived disease. This heterogeneity stems from diverse underlying pathologies, such as inflammatory, metabolic, and genetic factors. Recognizing these variations is crucial for developing more personalized oriented treatment rather than a "one-size-fits-all" approach. The burden of osteoarthritis is enormous, and the need for treatments that reduce pain and attendant disability for persons with osteoarthritis is critical. There are currently no medications approved by either the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) that have been demonstrated to arrest, slow or reverse progression of structural damage in the joint. ABOUT ENLIVEX Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening and life debilitating conditions. For more information, visit https://enlivex.com/. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would,” “could,” “intends,” “estimates,” “suggests,” “target,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, expected clinical trial results, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Enlivex's most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. ENLIVEX CONTACT Shachar Shlosberger, CFO Enlivex Therapeutics, Ltd. [email protected] INVESTOR RELATIONS CONTACT Dave Gentry, CEO RedChip Companies Inc. 1-407-644-4256 [email protected]